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BioZorb
BioZorb Marker

BioZorb Breast Marker

Hologic, Inc.’s BioZorb tissue marker, an FDA-approved implantable device for breast cancer treatment, was designed to provide a radiopaque marker for post-lumpectomy radiation therapy. The device, composed of a bioabsorbable polymer with embedded titanium clips, aimed to facilitate precise radiation delivery while minimizing the risk of long-term complications associated with permanent markers.

However, post-market surveillance revealed a significant incidence of adverse events. These included: pain, infection, rashes, device erosion, seromas, discomfort, and other issues. In some cases, the device migrated, necessitating additional medical interventions, including surgical removal.

In response to these findings, the FDA issued a Class I recall of the BioZorb tissue marker in 2024. This action underscores the importance of rigorous post-market surveillance and the need to promptly address emerging safety concerns with implantable medical devices.

FDA Recall

  1. May 2024 FDA issued a Class I recall of more than 53,000 BioZorb Markers distributed between April 2019 and April 2024
  2. October 2024 Hologic Inc issues voluntary recall to remove all lots of BioZorb Markers from the market

MDL

No MDL, Coordinated proceedings in District of Massachusetts, Judge Allison D Burroughs

Important Links

  1. https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices
  2. https://www.hologic.com/biozorb-3d-bioabsorbable-marker-important-recall-information
  3. https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication#:~:text=Safety%20Communications-,Update%3A%20Do%20Not%20Use%20BioZorb%20Marker%20Implantable,Marker%20Devices%3A%20FDA%20Safety%20Communication&text=The%20FDA%20has%20identified%20Hologic’s,you%20continue%20to%20use%20it.

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